BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 22104932 · Received May 29, 2025

    Report

    Report Number
    3008021110-2025-00047
    Event Type
    Injury
    Date Received
    May 29, 2025
    Date of Event
    March 26, 2025
    Report Date
    May 29, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    UDI-DI
    08033390001373
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE DHRS OF THE INVOLVED LOT #2119265, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 70 DEVICES MANUFACTURED WITH THAT LOT #. ACCORDING TO OUR RECORDS, AT LEAST 47 OUT OF 70 HUMERAL HEADS BELONGING TO LOT #2119265 AND STER. 2100333 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. DEVICE ANALYSIS: DEVICES INVOLVED WERE NOT RETURNED TO LIMA CORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS EVENT, SPECIFICALLY PRE-OPERATIVE X-RAYS WEREN'T ACCESSIBLE. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. THE CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #2119265. THE PATIENT TORE THEIR ROTATOR CUFF A COUPLE OF MONTHS FROM THE PRIMARY IMPLANT. THE EVENT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMA CORPORATE PMS DATA, THE REVISION RATE OF SMR ANATOMIC PROSTHESIS (TOTAL AND HEMI) DUE TO CUFF FAILURE IS (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMA CORPORATE CONTINUES MONITORING THE MARKET TO PROMPTLY DETECT ANY SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC TOTAL PROSTHESIS PERFORMED ON (B)(6) 2025, DUE TO CUFF FAILURE. IT WAS REPORTED THAT THE PATIENT TORE THEIR ROTATOR CUFF AND NEEDED A REVERSE TOTAL SHOULDER. THE FOLLOWING DEVICES WERE REMOVED: · SMR HUMERAL HEAD Ø42 MM (PRODUCT CODE 1322.09.420, LOT #2119265 - STER. 2100333). · LINER FOR METALBACK GLENOID STANDARD (PRODUCT CODE 1377.50.010, LOT #21AT2C8 - STER. 2200049). · SMR ADAPTOR TAPER (PRODUCT CODE AND LOT # UNKNOWN). · HUMERAL BODY (PRODUCT CODE AND LOT # UNKNOWN). THE PROSTHESIS WAS CONVERTED TO REVERSE CONFIGURATION: A DIA.36MM REVERSE LINER +6MM, A DIA.36MM GLENOSPHERE, A LATERALIZED CONNECTOR +4MM AND A REVERSE HUMERAL BODY WERE IMPLANTED. IT WAS REPORTED THAT THE PREVIOUS SURGERY WAS PERFORMED AT THE END OF (B)(6) 2025 (BUT THE EXACT DATE IS UNKNOWN). PATIENT IS A FEMALE, 64 YEARS OLD. EVENT HAPPENED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674106 SMR SHOULDER HUMERAL HEADS (COCRMO) DIA.42MM KWT LIMACORPORATE S.P.A. 1322.09.420 2119265 08033390001373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other